MAUDE Adverse Event Report: VYAIRE MEDICAL INC. BABY SAFE HYP INF,.5L,60CMH20,MANO,NRPR; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number BABY SAFE HYP INF,.5L,60CMH20,MANO,NRPR

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the baby safe hyp inf,.5l, 60cmh20, mano, nrpr does not provide accurate pressure.The pressure needed to be increased to maintain the flow to the bag.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: BABY SAFE HYP INF,.5L,60CMH20,MANO,NRPR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15523576
• MDR Text Key: 304892128
• Report Number: 8030673-2022-00270
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10885403294266
• UDI-Public: (01)10885403294266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BABY SAFE HYP INF,.5L,60CMH20,MANO,NRPR
• Device Catalogue Number: 5504BGL1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1